On DoD Radar: First Clinical Trial of MERS Vaccine Candidate

By Cheryl Pellerin
DoD News, Defense Media Activity

Scientists at the Walter Reed Army Institute of Research, or WRAIR, have started vaccinations in the first clinical trial to test the safety and immune response in people of a vaccine candidate to prevent MERS.

1. MERS-CoV

Transmission electron micrograph of Middle East respiratory syndrome coronavirus. National Institute of Allery and Infectious Disease photo

Transmission electron micrograph of Middle East respiratory syndrome coronavirus. National Institute of Allery and Infectious Disease photo

The virus circulates mainly in Saudi Arabia, where most cases have been reported, principal investigator Dr. Kayvon Modjarrad said in an interview this week. And scientists are sure the animal host of this coronavirus is the camel.

So why is the Defense Department interested in getting approval from the Food and Drug Administration for the vaccine to be used in people?

Because, Modjarrad says, the World Health Organization reports that MERS cases, infected in the Middle East and exported outside the region, have been confirmed in 26 countries, including two in the United States. And last year, he added, South Korea had the largest outbreak outside the Middle East.

With about 35,000 U.S. troops on the ground in Middle East countries that make up U.S. Central Command’s area of responsibility and more than 27,000 in South Korea, a MERS vaccine would be an important countermeasure for the Defense Department, the infectious disease specialist said.

“I think [the South Korea] outbreak really brought this full on the radar of the U.S. military, because we … rely on the local hospital infrastructure for some of the care of those servicemen and servicewomen, and the outbreak was propagated in South Korea by transmission in hospitals,” Modjarrad said, noting that infection in hospitals has been a big problem with MERS.

“So we have forces in the Middle East, we have forces on the Korean Peninsula, and this is transmitted by respiratory transmission, and it became very clear that it was a threat to our forces,” he said.

The most common MERS symptoms are fever, cough and shortness of breath. Older people and those with weakened immune systems are at greater risk for severe disease and death, and there are no FDA-approved MERS vaccines or treatments.

The coronavirus gets its name from images of it under the electron microscope, which shows that each virus particle is surrounded by a corona or halo.

3. SARS virus CDC 15531

Transmission electron micrograph of Middle East respiratory syndrome coronavirus. National Institute of Allery and Infectious Disease photo

Transmission electron micrograph of Middle East respiratory syndrome coronavirus. National Institute of Allery and Infectious Disease photo

Maybe you’ve heard of the other famous coronavirus disease — severe acute respiratory syndrome, or SARS, caused by the SARS-associated coronavirus, or SARS-CoV. MERS has killed 1,600 people since its emergence in 2012, and SARS infected 8,098 people in more than 24 countries between November 2002 and July 2003 and killed 774. No SARS cases have been reported since 2004.

Now we have MERS. But we also have a MERS vaccine in clinical trials.

2. Needle and Syringe NIH

Needle syringe with a vaccine bottle. National Institutes of Health photo

Needle syringe with a vaccine bottle. National Institutes of Health photo

Seventy-five participants will receive the vaccine at WRAIR’s Clinical Trial Center in Silver Spring, Maryland. The vaccine, called GLS-5300, is being co-developed by Inovio Pharmaceuticals and GeneOne Life Science Inc.

GLS-5300 is a DNA vaccine, in which a part of the virus that stimulates the immune system goes into a biological backbone that’s already been approved and used in other vaccines, such as the flu vaccine and even Ebola vaccine candidates.

So what Modjarrad called a “plug-and-play platform” for the vaccine candidate can be produced and ramped up very quickly.

And there’s something else. Right after they inject the DNA vaccine into a volunteer, that person gets a little electrical “zap” that helps the body’s muscle cells take up the DNA, Modjarrad said. “And then the DNA uses the machinery of our own cells to make the protein that then is really the vaccine that produces the immune response,” he explained.

“This is a really important step that we’ve taken to initiate a Phase I trial for MERS,” he added, “and I’m hopeful that this will inform studies to follow. But I can’t say exactly when we expect to have a MERS vaccine live and ready for licensing.”

Modjarrad says it’s important for people to just know what this virus is, because it’s a scary virus.

“About 1,600 people have been infected since the beginning in 2012, but 40 percent of those people have died. So low prevalence doesn’t mean low risk,” he said.

Related article:

Army Scientists Begin First MERS Vaccine Clinical Trial

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